Use of macimorelin in assessing growth hormone deficiency in children
AssigneeÆtema Zentaris GmbH
InventorsNicola Ammer, Michael Teifel, Beate Aue
Life of this patent
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Abstract
The present invention relates to a method for measuring growth hormone level in a human child, including a method of assessing pituitary-related growth hormone deficiency in a human child as a stand-alone test. The method comprises oral administration of an effective amount of macimorelin to the child, collecting from the child two or up to four post-administration blood samples within a range of about 90 minutes after administration, and determining the level of growth hormone in the samples. The method can be used for diagnosing pituitary-related growth hormone deficiency in a child when the peak level of determined growth hormone in the samples is below a cut-off value.
Claims20
A method for measuring growth hormone level in a human child, comprising:
- (a) orally administering to the child an effective amount of macimorelin;
- and
- (b) measuring growth hormone level in
- (i) two blood samples taken from the child at about 30 minutes after step (a) and at about 45 minutes after step (a),
- (ii) three blood samples taken from the child at about 30 minutes after step (a), at about 45 minutes or at about 60 minutes after step (a), and at about 60 minutes or at about 90 minutes after step (a), or
- (iii) four blood samples taken from the child at about 30 minutes after step (a), at about 45 minutes after step (a), at about 60 minutes after step (a), and at about 90 minutes after step (a),
- and wherein no additional blood sample is taken from the child.
A method for treating growth hormone deficiency in a child, comprising:
- (1) selecting a child who has been determined as having growth hormone deficiency by the following process:
- (a) orally administering to the child an effective amount of macimorelin;
- (b) measuring growth hormone level in
- (i) two blood samples taken from the child at about 30 minutes after step (a) and at about 45 minutes after step (a),
- (ii) three blood samples taken from the child at about 30 minutes after step (a), at about 45 minutes or at about 60 minutes after step (a), and at about 60 minutes or at about 90 minutes after step (a), or
- (iii) four blood samples taken from the child at about 30 minutes after step (a), at about 45 minutes after step (a), at about 60 minutes after step (a), and at about 90 minutes after step (a),
- wherein no additional blood sample is taken from the child;
- (c) comparing the highest growth hormone level in the blood samples obtained in step (b) with a predetermined threshold value;
- and
- (d) determining the child, whose highest growth hormone level in the blood samples obtained in step (b) is lower than the predetermined threshold level, as having growth hormone deficiency,
- and
- (2) administering to the child an effective amount of a therapeutic agent for growth hormone deficiency.
Dependencies are inferred from the claim text.